Surgical Treatment With Concentrated Growth Factor for Multiple Papillary Losses (CGF)

Efficiency of Concentrated Growth Factor in the Surgical Treatment of Multiple Adjacent Papillary Losses: a Controlled, Examiner-blinded Clinical Study

The aim of this study was to evaluate the efficacy of concentrated growth factor (CGF) in applied in the regenerative treatment of multiple adjacent papillary black triangles (MAPBT) occured as a result of soft tissue loss. Interdental papillary regeneration was evaluated with the change in the area of interproximal spaces calculated on each of the intraorally scanned images obtained with digital impressions of the interproximal space with irregular borders.This controlled, examiner-blinded, clinical study included of 40 patients with 120 open embrasures which resulted from papillary loss in adjacent teeth in the anterior maxillary esthetic zone resulting in black triangles (BTs). Then patients were randomly assigned to receive surgical regenerative periodontal treatment(test) or periodontal care(control)The test group was formed of 20 patients with 60 adjacent papillary defects . A control group was formed of 20 patients with 60 adjacent papillary defects.. A total of 480 images obtained with the digital impressions . Evaluations of the test group were made preoperatively and at 3, 6 and 12 months postoperatively. For the control group, oral hygiene instruction was provided. Control group is evaluated by the same procedure with test group but the surgical part is not performed. Lost interdental papillary area (PA)were calculated. In the test group, the percentage of papillary filling, the presence of keratinized gingiva, the thickness of papillary gingiva, blood thrombocyte count and mean platelet volume values(MPV) were recorded.

Study Overview

• Status: Completed
• Conditions: Papilla, Dentinal; Calcification
• Intervention / Treatment: Procedure: Concentrated Growth Factor

Detailed Description

The treatment of open gingival embrasures, which are also known as black triangles (BT) or black holes, and cause esthetic, functional and phonetic problems in the anterior region, has become an area of interest in current periodontal treatment.Surgical, non-surgical and prosthetic methods are applied in the treatment of BT, which can be seen in more than half of adults. This study aimed to evaluate the efficacy of concentrated growth factor (CGF) in regenerating interdental papillary of multiple adjacent papillary black triangles (MAPBT) occured as a result of soft tissue loss. Interdental papillary regeneration was evaluated with the change in the area of interproximal spaces calculated on each of the intraorally scanned images obtained with digital impressions of the interproximal space with irregular borders.

This controlled, examiner-blinded, randomized clinical study included 160 teeth of 40 patients with 120 open embrasures which resulted from papillary loss in adjacent teeth in the anterior maxillary esthetic zone resulting in black triangles (BTs). The test group was formed of 20 patients with 60 adjacent papillary defects undergoing minimally invasive surgery for papillary regeneration with CGF. A control group was formed of 20 patients with 60 adjacent papillary defects who were not included surgical treatment. A total of 480 images obtained with the digital impressions method of each interdental papillary region in each patient were uploaded to a special software. Evaluations of the test group were made preoperatively and at 3, 6 and 12 months postoperatively. For the control group, oral hygiene instruction was provided. Control group is evaluated by the same procedure with test group but the surgical part is not performed. Lost interdental papillary area (PA)were calculated between the two central teeth, between the lateral and central teeth, and between the lateral and canine teeth prior to the treatment and at pro-treatment periods of 3, 6 and 12 months in both of the groups. In the test group, the percentage of papillary filling, the presence of keratinized gingiva, the thickness of papillary gingiva, blood thrombocyte count and MPV values were recorded.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06510
      • Gazi University Faculty of Dentistry Department of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of interdental papillary losses in the maxillary anterior teeth, between the adjacent central teeth, the central and lateral teeth and the lateral and canine teeth
• The presence of a contact point in the maxillary anterior teeth
• optimal facial keratinized gingiva/ keratinized gingiva must be more than 2mm

Exclusion Criteria:

• pregnancy or
• breast-feeding,
• palatal and gingival recession,
• attachment loss,
• high labial frenulum.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Concentrated Growth Factor; plaque control, scaling and root planing if required, surgical application of CGF	Procedure: Concentrated Growth Factor; surgical treatment with CGF for papilla regeneration
No Intervention: Control Group; plaque control, scaling and root planing if required

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the percentage of papillary fill(PF)	The percentage of PF was also calculated as ([ Lost Papillary area(PA) preoperation - PA postoperation] / PA preoperation) x 100%.	Change from 3 months percentage of papillary fill at 6 months

Collaborators and Investigators

• Sponsor: Gazi University
• Collaborators: Ankara University
• Investigators: Principal Investigator: zeynep Turgut Çankaya, PhD,Dr, Gazi University, Faculty of Dentistry,Department of Periodontology

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2017
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): August 12, 2018

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: CGF; lost interdental papilla
• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 36290600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No